BaciiM

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BaciiM

Classes

Ophthalmological Anti-infectives
Other Antibiotics
Topical Polypeptide Anti-infectives, Plain or in Combination

Administration

NOTE: One unit bacitracin is equivalent to 0.026 mg bacitracin.

Injectable Administration

Visually inspect parenteral products for particulate matter and discoloration prior to administration whenever solution and container permit.

Intramuscular Administration

For intramuscular injection only; do not give intravenously.
Patients should be well-hydrated during IM bacitracin therapy, and their urine should be kept at a pH of 6 or higher by administering sodium bicarbonate or other urinary alkalinizer to decrease renal toxicity. Urine output should be maintained.
 
Reconstitution:
Do not use diluents containing parabens since precipitation of bacitracin may result.
Reconstitute 50,000 units with 9.8 mL of 2% procaine HCl to give a concentration of 5000 units/mL.
Alternatively, reconstitute 50,000 units with 50 mL of 0.9% Sodium Chloride injection to give a solution containing bacitracin 1000 units/mL; further dilute this solution with 50 mL of 2% procaine HCl injection to give a solution containing 500 units/mL.
The reconstituted solution is stable for 1 week under refrigeration (2 to 15 degrees C).
 
Intramuscular injection:
Inject deeply into upper outer quadrant of the gluteus maximus, alternating left and right.
Avoid multiple injections in the same region because of pain associated with the injections.

Topical Administration

Cleanse affected area before topical application.

Cream/Ointment/Lotion Formulations

Available as a topical non-prescription ointment.
Apply topically to affected area. Treated area may be covered with sterile gauze dressing if desired.

Extemporaneous Compounding-Topical

A topical irrigation solution may be compounded by dissolving appropriate amount of bacitracin injection or bacitracin compounding powder in 0.9% Sodium Chloride injection or sterile water for injection for a final concentration of 250 to 1000 units/mL. These solutions degrade rapidly if kept at room temperature. Store refrigerated at 2 to 8 degrees C for no longer than 1 week to maintain potency. Do not freeze.

Ophthalmic Administration

For topical ophthalmic administration only.
Instruct patient on proper instillation of eye ointment (see Patient Information).
Patients should not wear contact lenses if they have an ocular infection.
Do not to touch the tip of the applicator to the eye, eyelid, fingertips, or other surface.
Apply directly into the conjunctival sac. In blepharitis all scales and crusts should be carefully removed and the ointment then spread uniformly over the lid margins.
Keep tightly closed when not in use.
To avoid risk of infection, use one open tube per individual patient.

Adverse Reactions
Severe

proteinuria / Delayed / Incidence not known
renal tubular necrosis / Delayed / Incidence not known
azotemia / Delayed / Incidence not known
nephrotoxicity / Delayed / Incidence not known
renal failure (unspecified) / Delayed / Incidence not known
oliguria / Early / Incidence not known
anaphylactoid reactions / Rapid / Incidence not known
anaphylactic shock / Rapid / Incidence not known
respiratory arrest / Rapid / Incidence not known
C. difficile-associated diarrhea / Delayed / Incidence not known

Moderate

hematuria / Delayed / Incidence not known
eosinophilia / Delayed / Incidence not known
myasthenia / Delayed / Incidence not known
respiratory depression / Rapid / Incidence not known
superinfection / Delayed / Incidence not known
pseudomembranous colitis / Delayed / Incidence not known
blurred vision / Early / Incidence not known

Mild

cylindruria / Delayed / Incidence not known
fever / Early / Incidence not known
urticaria / Rapid / Incidence not known
pruritus / Rapid / Incidence not known
vomiting / Early / Incidence not known
rash / Early / Incidence not known
injection site reaction / Rapid / Incidence not known
nausea / Early / Incidence not known

Boxed Warning
Nephrotoxicity, oliguria, renal failure, renal impairment

Intramuscular bacitracin is associated with a high incidence of bacitracin-induced nephrotoxicity. Renal failure may occur due to glomerular and tubular necrosis. Bacitracin nephrotoxicity is related to the daily dose and duration of therapy. Intramuscular bacitracin should be used with caution, if at all, in patients with preexisting renal impairment or renal failure and systemic bacitracin use should be restricted to severe infections due to susceptible organisms. It should also be used only where adequate laboratory facilities are available and when constant supervision of the patient is possible. Patients receiving IM bacitracin should undergo microscopic urinalysis regularly and renal function determination both before and during therapy. Patients receiving IM bacitracin should have an adequate intake of fluids, and a urinary pH of 6 should be maintained, by giving sodium bicarbonate or other alkali, to decrease irritation. Patients who develop oliguria while maintaining normal fluid intake, or who experience progressive azotemia during IM bacitracin therapy should discontinue treatment. Avoid using other nephrotoxic drugs, particularly kanamycin, neomycin, polymyxin B, polymyxin E (colistin), and streptomycin.

Common Brand Names

AK-Tracin, Baciguent, BaciiM, Ocu-Tracin

Dea Class

OTC, Rx

Description

Ophthalmic, parenteral, and topical polypeptide antibiotic
Used for superficial ocular infections involving the conjunctiva and/or cornea, infants with pneumonia and empyema due to susceptible staphylococci, and infection prevention in minor cuts, scrapes, or burns
Active mainly against gram-positive bacteria

Dosage And Indications
For the prevention of skin and skin structure infections after a minor compromise in skin integrity such as minor burns or skin abrasion. Topical dosage Adults, Adolescents, and Children

Apply a thin film 2 to 3 times per day, not to exceed 5 times per day depending upon the severity of the infection. Topical administration should be used for no longer than 7 days unless directed by the patient's prescriber or health care provider.

For the treatment of superficial ophthalmic infection involving the conjunctiva (i.e., bacterial conjunctivitis) and/or cornea. Ophthalmic dosage (ophthalmic ointment) Adults

0.5 inch ribbon in the affected eye(s) 1 to 3 times daily.

Infants, Children, and Adolescents

0.5 inch ribbon in the affected eye(s) 1 to 3 times daily.

For the treatment of pneumonia or pleural empyema caused by susceptible Staphylococci.
Due to the potential for nephrotoxicity, restrict bacitracin intramuscular therapy to infants with susceptible staphylococcal pneumonia infections and pleural empyema. Intramuscular bacitracin should only be used where adequate laboratory facilities are available and when constant supervision of the patient is possible.
Intramuscular dosage Infants weighing more than 2.5 kg

1,000 units/kg/day IM divided every 8 to 12 hours.[31047]

Infants weighing 2.5 kg or less

900 units/kg/day IM divided every 8 to 12 hours.

For the treatment and eradication of enteric vancomycin-resistant enterococci (VRE)† in the stool. Oral dosage Adults

Oral bacitracin has been reported to be effective for the treatment and eradication of vancomycin-resistant Enterococcus (VRE) in the stool. In a prospective observational study of patients on a renal ward, treatment with oral bacitracin 75,000 units/15 mL PO 4 times daily plus doxycycline (100 mg PO once daily) was NOT efficacious in reducing the carriage of VRE beyond the 2-week treatment period. Although, during the treatment period, the combination did reduce the quantitative enterococcal counts in the stool approximately 3 log/kg, but this decrease did not continue.

†Indicates off-label use

Dosing Considerations
Hepatic Impairment

No dosage adjustment needed; however, if used systemically, be alert for effects on renal function, which may precipitate hepato-renal failure.

Renal Impairment

Due to the severe nephrotoxicity of bacitracin, systemic use is not recommended in patients with renal impairment or failure. Should nephrotoxicity occur during bacitracin treatment, therapy should be discontinued.

Drug Interactions

Acetaminophen; Aspirin, ASA; Caffeine: (Minor) Additive nephrotoxicity may occur with concurrent use of systemic bacitracin and other nephrotoxic agents, including salicylates. Topical administration of any preparation containing bacitracin, especially when applied to large surface areas, also should not be given with other drugs that have a nephrotoxic potential.
Acetaminophen; Aspirin: (Minor) Additive nephrotoxicity may occur with concurrent use of systemic bacitracin and other nephrotoxic agents, including salicylates. Topical administration of any preparation containing bacitracin, especially when applied to large surface areas, also should not be given with other drugs that have a nephrotoxic potential.
Acetaminophen; Aspirin; Diphenhydramine: (Minor) Additive nephrotoxicity may occur with concurrent use of systemic bacitracin and other nephrotoxic agents, including salicylates. Topical administration of any preparation containing bacitracin, especially when applied to large surface areas, also should not be given with other drugs that have a nephrotoxic potential.
Amikacin: (Minor) Additive nephrotoxicity may occur with concurrent use of bacitracin and other nephrotoxic agents. When possible, avoid concomitant administration of systemic bacitracin and other nephrotoxic drugs such as aminoglycosides (particularly kanamycin, streptomycin, and neomycin). Use of topically administrated preparations containing bacitracin, especially when applied to large surface areas, with aminoglycosides may have additive nephrotoxic potential.
Aminosalicylate sodium, Aminosalicylic acid: (Minor) Additive nephrotoxicity may occur with concurrent use of systemic bacitracin and other nephrotoxic agents, including salicylates. Topical administration of any preparation containing bacitracin, especially when applied to large surface areas, also should not be given with other drugs that have a nephrotoxic potential.
Amphotericin B lipid complex (ABLC): (Minor) Additive nephrotoxicity may occur with concurrent use of systemic bacitracin and other nephrotoxic agents, such as amphoteracin B; when possible, avoid concomitant administration. Topical administration of any preparation containing bacitracin, especially when applied to large surface areas, should not be given with other drugs that have a nephrotoxic potential.
Amphotericin B liposomal (LAmB): (Minor) Additive nephrotoxicity may occur with concurrent use of systemic bacitracin and other nephrotoxic agents, such as amphoteracin B; when possible, avoid concomitant administration. Topical administration of any preparation containing bacitracin, especially when applied to large surface areas, should not be given with other drugs that have a nephrotoxic potential.
Amphotericin B: (Minor) Additive nephrotoxicity may occur with concurrent use of systemic bacitracin and other nephrotoxic agents, such as amphoteracin B; when possible, avoid concomitant administration. Topical administration of any preparation containing bacitracin, especially when applied to large surface areas, should not be given with other drugs that have a nephrotoxic potential.
Aspirin, ASA: (Minor) Additive nephrotoxicity may occur with concurrent use of systemic bacitracin and other nephrotoxic agents, including salicylates. Topical administration of any preparation containing bacitracin, especially when applied to large surface areas, also should not be given with other drugs that have a nephrotoxic potential.
Aspirin, ASA; Butalbital; Caffeine: (Minor) Additive nephrotoxicity may occur with concurrent use of systemic bacitracin and other nephrotoxic agents, including salicylates. Topical administration of any preparation containing bacitracin, especially when applied to large surface areas, also should not be given with other drugs that have a nephrotoxic potential.
Aspirin, ASA; Caffeine: (Minor) Additive nephrotoxicity may occur with concurrent use of systemic bacitracin and other nephrotoxic agents, including salicylates. Topical administration of any preparation containing bacitracin, especially when applied to large surface areas, also should not be given with other drugs that have a nephrotoxic potential.
Aspirin, ASA; Caffeine; Orphenadrine: (Minor) Additive nephrotoxicity may occur with concurrent use of systemic bacitracin and other nephrotoxic agents, including salicylates. Topical administration of any preparation containing bacitracin, especially when applied to large surface areas, also should not be given with other drugs that have a nephrotoxic potential.
Aspirin, ASA; Carisoprodol: (Minor) Additive nephrotoxicity may occur with concurrent use of systemic bacitracin and other nephrotoxic agents, including salicylates. Topical administration of any preparation containing bacitracin, especially when applied to large surface areas, also should not be given with other drugs that have a nephrotoxic potential.
Aspirin, ASA; Carisoprodol; Codeine: (Minor) Additive nephrotoxicity may occur with concurrent use of systemic bacitracin and other nephrotoxic agents, including salicylates. Topical administration of any preparation containing bacitracin, especially when applied to large surface areas, also should not be given with other drugs that have a nephrotoxic potential.
Aspirin, ASA; Citric Acid; Sodium Bicarbonate: (Minor) Additive nephrotoxicity may occur with concurrent use of systemic bacitracin and other nephrotoxic agents, including salicylates. Topical administration of any preparation containing bacitracin, especially when applied to large surface areas, also should not be given with other drugs that have a nephrotoxic potential.
Aspirin, ASA; Dipyridamole: (Minor) Additive nephrotoxicity may occur with concurrent use of systemic bacitracin and other nephrotoxic agents, including salicylates. Topical administration of any preparation containing bacitracin, especially when applied to large surface areas, also should not be given with other drugs that have a nephrotoxic potential.
Aspirin, ASA; Omeprazole: (Minor) Additive nephrotoxicity may occur with concurrent use of systemic bacitracin and other nephrotoxic agents, including salicylates. Topical administration of any preparation containing bacitracin, especially when applied to large surface areas, also should not be given with other drugs that have a nephrotoxic potential.
Aspirin, ASA; Oxycodone: (Minor) Additive nephrotoxicity may occur with concurrent use of systemic bacitracin and other nephrotoxic agents, including salicylates. Topical administration of any preparation containing bacitracin, especially when applied to large surface areas, also should not be given with other drugs that have a nephrotoxic potential.
Benzoic Acid; Hyoscyamine; Methenamine; Methylene Blue; Phenyl Salicylate: (Minor) Additive nephrotoxicity may occur with concurrent use of systemic bacitracin and other nephrotoxic agents, including salicylates. Topical administration of any preparation containing bacitracin, especially when applied to large surface areas, also should not be given with other drugs that have a nephrotoxic potential.
Bismuth Subsalicylate: (Minor) Additive nephrotoxicity may occur with concurrent use of systemic bacitracin and other nephrotoxic agents, including salicylates. Topical administration of any preparation containing bacitracin, especially when applied to large surface areas, also should not be given with other drugs that have a nephrotoxic potential.
Bismuth Subsalicylate; Metronidazole; Tetracycline: (Minor) Additive nephrotoxicity may occur with concurrent use of systemic bacitracin and other nephrotoxic agents, including salicylates. Topical administration of any preparation containing bacitracin, especially when applied to large surface areas, also should not be given with other drugs that have a nephrotoxic potential.
Bumetanide: (Minor) Additive nephrotoxicity may occur with concurrent use of systemic bacitracin and other nephrotoxic agents. When possible, avoid concomitant administration of systemic bacitracin and other nephrotoxic drugs such as loop diuretics. Topical administration of any preparation containing bacitracin, especially when applied to large surface areas, also should not be given with other drugs that have a nephrotoxic potential. (Minor) Additive nephrotoxicity may occur with concurrent use of these medicines. When possible, avoid concomitant administration of systemic bacitracin and loop diuretics. Use of topically administrated preparations containing bacitracin, especially when applied to large surface areas, may have additive nephrotoxic potential with loop diuretics.
Butalbital; Aspirin; Caffeine; Codeine: (Minor) Additive nephrotoxicity may occur with concurrent use of systemic bacitracin and other nephrotoxic agents, including salicylates. Topical administration of any preparation containing bacitracin, especially when applied to large surface areas, also should not be given with other drugs that have a nephrotoxic potential.
Capreomycin: (Major) Since capreomycin is eliminated by the kidney, coadministration with other potentially nephrotoxic drugs, including bacitracin, may increase serum concentrations of either drug. Theoretically, the chronic coadministration of these drugs may increase the risk of developing nephrotoxicity, even in patients who have normal renal function. Monitor patients for changes in renal function if these drugs are coadministered.
Choline Salicylate; Magnesium Salicylate: (Minor) Additive nephrotoxicity may occur with concurrent use of systemic bacitracin and other nephrotoxic agents, including salicylates. Topical administration of any preparation containing bacitracin, especially when applied to large surface areas, also should not be given with other drugs that have a nephrotoxic potential.
Cidofovir: (Contraindicated) The administration of cidofovir with another potentially nephrotoxic agent, such as bacitracin, is contraindicated. Bacitracin should be discontinued at least 7 days prior to beginning cidofovir.
Cisplatin: (Moderate) Closely monitor renal function if concomitant use with cisplatin and bacitracin is necessary. Both drugs can cause nephrotoxicity, which may be exacerbated with the use of additional nephrotoxins.
Colistimethate, Colistin, Polymyxin E: (Major) Coadministration of these drugs may increase the risk of developing nephrotoxicity, even in patients who have normal renal function. Monitor patients for changes in renal function if these drugs are coadministered. Since colistimethate sodium is eliminated by the kidney, coadministration with other potentially nephrotoxic drugs, including bacitracin, may increase serum concentrations of either drug.
Colistin: (Major) Coadministration of these drugs may increase the risk of developing nephrotoxicity, even in patients who have normal renal function. Monitor patients for changes in renal function if these drugs are coadministered. Since colistimethate sodium is eliminated by the kidney, coadministration with other potentially nephrotoxic drugs, including bacitracin, may increase serum concentrations of either drug.
Cyclosporine: (Minor) Additive nephrotoxicity may occur with concurrent use of bacitracin and other nephrotoxic agents. When possible, avoid concomitant administration of systemic bacitracin and other nephrotoxic drugs such as cyclosporine. Use of topically administrated preparations containing bacitracin, especially when applied to large surface areas, may have additive nephrotoxic potential with cyclosporine.
Doravirine; Lamivudine; Tenofovir disoproxil fumarate: (Moderate) Tenofovir-containing products should be avoided with concurrent or recent use of a nephrotoxic agent, such as bacitracin. Tenofovir is primarily excreted via the kidneys by a combination of glomerular filtration and active tubular secretion. Coadministration of tenofovir with drugs that are eliminated by active tubular secretion may increase concentrations of tenofovir and/or the co-administered drug. Drugs that decrease renal function may also increase concentrations of tenofovir. Renal impairment, which may include hypophosphatemia, has been reported with the use of tenofovir with a majority of the cases occurring in patients who have underlying systemic or renal disease or who are concurrently taking nephrotoxic agents. Monitor patients receiving concomitant nephrotoxic agents for changes in serum creatinine and phosphorus.
Efavirenz; Emtricitabine; Tenofovir Disoproxil Fumarate: (Moderate) Tenofovir-containing products should be avoided with concurrent or recent use of a nephrotoxic agent, such as bacitracin. Tenofovir is primarily excreted via the kidneys by a combination of glomerular filtration and active tubular secretion. Coadministration of tenofovir with drugs that are eliminated by active tubular secretion may increase concentrations of tenofovir and/or the co-administered drug. Drugs that decrease renal function may also increase concentrations of tenofovir. Renal impairment, which may include hypophosphatemia, has been reported with the use of tenofovir with a majority of the cases occurring in patients who have underlying systemic or renal disease or who are concurrently taking nephrotoxic agents. Monitor patients receiving concomitant nephrotoxic agents for changes in serum creatinine and phosphorus.
Efavirenz; Lamivudine; Tenofovir Disoproxil Fumarate: (Moderate) Tenofovir-containing products should be avoided with concurrent or recent use of a nephrotoxic agent, such as bacitracin. Tenofovir is primarily excreted via the kidneys by a combination of glomerular filtration and active tubular secretion. Coadministration of tenofovir with drugs that are eliminated by active tubular secretion may increase concentrations of tenofovir and/or the co-administered drug. Drugs that decrease renal function may also increase concentrations of tenofovir. Renal impairment, which may include hypophosphatemia, has been reported with the use of tenofovir with a majority of the cases occurring in patients who have underlying systemic or renal disease or who are concurrently taking nephrotoxic agents. Monitor patients receiving concomitant nephrotoxic agents for changes in serum creatinine and phosphorus.
Elvitegravir; Cobicistat; Emtricitabine; Tenofovir Disoproxil Fumarate: (Moderate) Tenofovir-containing products should be avoided with concurrent or recent use of a nephrotoxic agent, such as bacitracin. Tenofovir is primarily excreted via the kidneys by a combination of glomerular filtration and active tubular secretion. Coadministration of tenofovir with drugs that are eliminated by active tubular secretion may increase concentrations of tenofovir and/or the co-administered drug. Drugs that decrease renal function may also increase concentrations of tenofovir. Renal impairment, which may include hypophosphatemia, has been reported with the use of tenofovir with a majority of the cases occurring in patients who have underlying systemic or renal disease or who are concurrently taking nephrotoxic agents. Monitor patients receiving concomitant nephrotoxic agents for changes in serum creatinine and phosphorus.
Emtricitabine; Rilpivirine; Tenofovir Disoproxil Fumarate: (Moderate) Tenofovir-containing products should be avoided with concurrent or recent use of a nephrotoxic agent, such as bacitracin. Tenofovir is primarily excreted via the kidneys by a combination of glomerular filtration and active tubular secretion. Coadministration of tenofovir with drugs that are eliminated by active tubular secretion may increase concentrations of tenofovir and/or the co-administered drug. Drugs that decrease renal function may also increase concentrations of tenofovir. Renal impairment, which may include hypophosphatemia, has been reported with the use of tenofovir with a majority of the cases occurring in patients who have underlying systemic or renal disease or who are concurrently taking nephrotoxic agents. Monitor patients receiving concomitant nephrotoxic agents for changes in serum creatinine and phosphorus.
Emtricitabine; Tenofovir Disoproxil Fumarate: (Moderate) Tenofovir-containing products should be avoided with concurrent or recent use of a nephrotoxic agent, such as bacitracin. Tenofovir is primarily excreted via the kidneys by a combination of glomerular filtration and active tubular secretion. Coadministration of tenofovir with drugs that are eliminated by active tubular secretion may increase concentrations of tenofovir and/or the co-administered drug. Drugs that decrease renal function may also increase concentrations of tenofovir. Renal impairment, which may include hypophosphatemia, has been reported with the use of tenofovir with a majority of the cases occurring in patients who have underlying systemic or renal disease or who are concurrently taking nephrotoxic agents. Monitor patients receiving concomitant nephrotoxic agents for changes in serum creatinine and phosphorus.
Ethacrynic Acid: (Minor) Additive nephrotoxicity may occur with concurrent use of systemic bacitracin and other nephrotoxic agents. When possible, avoid concomitant administration of systemic bacitracin and other nephrotoxic drugs such as loop diuretics. Topical administration of any preparation containing bacitracin, especially when applied to large surface areas, also should not be given with other drugs that have a nephrotoxic potential. (Minor) Additive nephrotoxicity may occur with concurrent use of these medicines. When possible, avoid concomitant administration of systemic bacitracin and loop diuretics. Use of topically administrated preparations containing bacitracin, especially when applied to large surface areas, may have additive nephrotoxic potential with loop diuretics.
Foscarnet: (Minor) Additive nephrotoxicity may occur with concurrent use of systemic bacitracin and other nephrotoxic agents. When possible, avoid concomitant administration of systemic bacitracin and other nephrotoxic drugs such as foscarnet. Use of topically administrated preparations containing bacitracin, especially when applied to large surface areas, may have additive nephrotoxic potential with foscarnet.
Furosemide: (Minor) Additive nephrotoxicity may occur with concurrent use of systemic bacitracin and other nephrotoxic agents. When possible, avoid concomitant administration of systemic bacitracin and other nephrotoxic drugs such as loop diuretics. Topical administration of any preparation containing bacitracin, especially when applied to large surface areas, also should not be given with other drugs that have a nephrotoxic potential. (Minor) Additive nephrotoxicity may occur with concurrent use of these medicines. When possible, avoid concomitant administration of systemic bacitracin and loop diuretics. Use of topically administrated preparations containing bacitracin, especially when applied to large surface areas, may have additive nephrotoxic potential with loop diuretics.
Ganciclovir: (Minor) Concurrent use of nephrotoxic agents, including systemic bacitracin, with ganciclovir should be done cautiously to avoid additive nephrotoxicity.
General anesthetics: (Moderate) General anesthetics should be used cautiously in patients receiving systemic bacitracin. Systemic bacitracin may act synergistcally to increase or prolong skeletal muscle relaxation produced by neuromuscular blocking agents and/or general anesthetics. If bacitracin is administered parenterally during surgery, there may be increased skeletal muscle relaxation, and postoperative use may reinstate neuromuscular blockade.
Gentamicin: (Minor) Additive nephrotoxicity may occur with concurrent use of bacitracin and other nephrotoxic agents. When possible, avoid concomitant administration of systemic bacitracin and other nephrotoxic drugs such as aminoglycosides (particularly kanamycin, streptomycin, and neomycin). Use of topically administrated preparations containing bacitracin, especially when applied to large surface areas, with aminoglycosides may have additive nephrotoxic potential.
Hyaluronidase, Recombinant; Immune Globulin: (Moderate) Immune Globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like bacitracin. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Also, closely monitor renal function.
Hyoscyamine; Methenamine; Methylene Blue; Phenyl Salicylate; Sodium Biphosphate: (Minor) Additive nephrotoxicity may occur with concurrent use of systemic bacitracin and other nephrotoxic agents, including salicylates. Topical administration of any preparation containing bacitracin, especially when applied to large surface areas, also should not be given with other drugs that have a nephrotoxic potential.
Immune Globulin IV, IVIG, IGIV: (Moderate) Immune Globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like bacitracin. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Also, closely monitor renal function.
Inotersen: (Moderate) Use caution with concomitant use of inotersen and bacitracin due to the risk of glomerulonephritis and nephrotoxicity.
Lamivudine; Tenofovir Disoproxil Fumarate: (Moderate) Tenofovir-containing products should be avoided with concurrent or recent use of a nephrotoxic agent, such as bacitracin. Tenofovir is primarily excreted via the kidneys by a combination of glomerular filtration and active tubular secretion. Coadministration of tenofovir with drugs that are eliminated by active tubular secretion may increase concentrations of tenofovir and/or the co-administered drug. Drugs that decrease renal function may also increase concentrations of tenofovir. Renal impairment, which may include hypophosphatemia, has been reported with the use of tenofovir with a majority of the cases occurring in patients who have underlying systemic or renal disease or who are concurrently taking nephrotoxic agents. Monitor patients receiving concomitant nephrotoxic agents for changes in serum creatinine and phosphorus.
Loop diuretics: (Minor) Additive nephrotoxicity may occur with concurrent use of systemic bacitracin and other nephrotoxic agents. When possible, avoid concomitant administration of systemic bacitracin and other nephrotoxic drugs such as loop diuretics. Topical administration of any preparation containing bacitracin, especially when applied to large surface areas, also should not be given with other drugs that have a nephrotoxic potential. (Minor) Additive nephrotoxicity may occur with concurrent use of these medicines. When possible, avoid concomitant administration of systemic bacitracin and loop diuretics. Use of topically administrated preparations containing bacitracin, especially when applied to large surface areas, may have additive nephrotoxic potential with loop diuretics.
Magnesium Salicylate: (Minor) Additive nephrotoxicity may occur with concurrent use of systemic bacitracin and other nephrotoxic agents, including salicylates. Topical administration of any preparation containing bacitracin, especially when applied to large surface areas, also should not be given with other drugs that have a nephrotoxic potential.
Mannitol: (Major) Avoid use of mannitol and systemic bacitracin, if possible. Concomitant administration of nephrotoxic drugs, such as bacitracin, increases the risk of renal failure after administration of mannitol.
Methenamine; Sodium Salicylate: (Minor) Additive nephrotoxicity may occur with concurrent use of systemic bacitracin and other nephrotoxic agents, including salicylates. Topical administration of any preparation containing bacitracin, especially when applied to large surface areas, also should not be given with other drugs that have a nephrotoxic potential.
Methohexital: (Moderate) Systemic bacitracin may act synergistcally to increase or prolong skeletal muscle relaxation produced by neuromuscular blocking agents and/or general anesthetics.
Neomycin: (Minor) Additive nephrotoxicity may occur with concurrent use of bacitracin and other nephrotoxic agents. When possible, avoid concomitant administration of systemic bacitracin and other nephrotoxic drugs such as aminoglycosides (particularly kanamycin, streptomycin, and neomycin). Use of topically administrated preparations containing bacitracin, especially when applied to large surface areas, with aminoglycosides may have additive nephrotoxic potential.
Neuromuscular blockers: (Minor) Concomitant use of neuromuscular blockers and systemic bacitracin may prolong neuromuscular blockade. The use of a peripheral nerve stimulator is strongly recommended to evaluate the level of neuromuscular blockade, to assess the need for additional doses of neuromuscular blocker, and to determine whether adjustments need to be made to the dose with subsequent administration.
Nonsteroidal antiinflammatory drugs: (Major) Avoid concurrent use of bacitracin with nonsteroidal antiinflammatory drugs. Coadministration may increase the risk for drug-induced nephrotoxicity.
Oral Contraceptives: (Moderate) It would be prudent to recommend alternative or additional contraception when oral contraceptives (OCs) are used in conjunction with antibiotics. It was previously thought that antibiotics may decrease the effectiveness of OCs containing estrogens due to stimulation of metabolism or a reduction in enterohepatic circulation via changes in GI flora. One retrospective study reviewed the literature to determine the effects of oral antibiotics on the pharmacokinetics of contraceptive estrogens and progestins, and also examined clinical studies in which the incidence of pregnancy with OCs and antibiotics was reported. It was concluded that the antibiotics ampicillin, ciprofloxacin, clarithromycin, doxycycline, metronidazole, ofloxacin, roxithromycin, temafloxacin, and tetracycline did not alter plasma concentrations of OCs. Antituberculous drugs (e.g., rifampin) were the only agents associated with OC failure and pregnancy. Based on the study results, these authors recommended that back-up contraception may not be necessary if OCs are used reliably during oral antibiotic use. Another review concurred with these data, but noted that individual patients have been identified who experienced significant decreases in plasma concentrations of combined OC components and who appeared to ovulate; the agents most often associated with these changes were rifampin, tetracyclines, and penicillin derivatives. These authors concluded that because females most at risk for OC failure or noncompliance may not be easily identified and the true incidence of such events may be under-reported, and given the serious consequence of unwanted pregnancy, that recommending an additional method of contraception during short-term antibiotic use may be justified. During long-term antibiotic administration, the risk for drug interaction with OCs is less clear, but alternative or additional contraception may be advisable in selected circumstances. Data regarding progestin-only contraceptives or for newer combined contraceptive deliveries (e.g., patches, rings) are not available.
Paromomycin: (Minor) Additive nephrotoxicity may occur with concurrent use of bacitracin and other nephrotoxic agents. When possible, avoid concomitant administration of systemic bacitracin and other nephrotoxic drugs such as aminoglycosides (particularly kanamycin, streptomycin, and neomycin). Use of topically administrated preparations containing bacitracin, especially when applied to large surface areas, with aminoglycosides may have additive nephrotoxic potential.
Pentamidine: (Moderate) Additive nephrotoxicity may occur. Both bacitracin and pentamidine may cause a decline in renal function. Bacitracin renal toxicity may occur when the drug is systemically administered or given via topical administration over large surface areas or in prolonged topical use (e.g., severe burns). When possible, avoid concomitant administration of systemic bacitracin and other nephrotoxic drugs such as intravenous pentamidine. Monitor renal function closely.
Polymyxin B: (Major) Additive nephrotoxicity may occur with concurrent use of systemic bacitracin and other nephrotoxic agents, such as polymyxin B; when possible, avoid concomitant administration. Topical administration of any preparation containing bacitracin, especially when applied to large surface areas, should also not be given with other drugs that have a nephrotoxic potential.
Pyridostigmine: (Moderate) Parenteral administration of high doses of certain antibiotics such as bacitracin may intensify or produce neuromuscular block through their own pharmacologic actions. If unexpected prolongation of neuromuscular block or resistance to its reversal with pyridostigmine occurs, consider the possibility of an antibiotic effect.
Salicylates: (Minor) Additive nephrotoxicity may occur with concurrent use of systemic bacitracin and other nephrotoxic agents, including salicylates. Topical administration of any preparation containing bacitracin, especially when applied to large surface areas, also should not be given with other drugs that have a nephrotoxic potential.
Salsalate: (Minor) Additive nephrotoxicity may occur with concurrent use of systemic bacitracin and other nephrotoxic agents, including salicylates. Topical administration of any preparation containing bacitracin, especially when applied to large surface areas, also should not be given with other drugs that have a nephrotoxic potential.
Streptomycin: (Minor) Additive nephrotoxicity may occur with concurrent use of bacitracin and other nephrotoxic agents. When possible, avoid concomitant administration of systemic bacitracin and other nephrotoxic drugs such as aminoglycosides (particularly kanamycin, streptomycin, and neomycin). Use of topically administrated preparations containing bacitracin, especially when applied to large surface areas, with aminoglycosides may have additive nephrotoxic potential.
Tacrolimus: (Minor) Additive nephrotoxicity may occur with concurrent use of these medicines. When possible, avoid concomitant administration of systemic bacitracin and other nephrotoxic drugs such as tacrolimus. Use of topically administrated preparations containing bacitracin, especially when applied to large surface areas, may have additive nephrotoxic potential.
Telavancin: (Minor) Concurrent or sequential use of telavancin with other potentially nephrotoxic drugs such as systemic bacitracin may lead to additive nephrotoxicity. Closely monitor renal function and adjust telavancin doses based on calculated creatinine clearance.
Tenofovir Alafenamide: (Moderate) Monitor for changes in renal function if tenofovir alafenamide is administered in combination with a nephrotoxic agent, such as bacitracin. Tenofovir is primarily excreted via the kidneys by a combination of glomerular filtration and active tubular secretion. Coadministration of tenofovir alafenamide with a drug that reduces renal function or competes for active tubular secretion may increase concentrations of tenofovir and other renally eliminated drugs; thus, increasing the risk of developing renal-related adverse reactions.
Tenofovir Disoproxil Fumarate: (Moderate) Tenofovir-containing products should be avoided with concurrent or recent use of a nephrotoxic agent, such as bacitracin. Tenofovir is primarily excreted via the kidneys by a combination of glomerular filtration and active tubular secretion. Coadministration of tenofovir with drugs that are eliminated by active tubular secretion may increase concentrations of tenofovir and/or the co-administered drug. Drugs that decrease renal function may also increase concentrations of tenofovir. Renal impairment, which may include hypophosphatemia, has been reported with the use of tenofovir with a majority of the cases occurring in patients who have underlying systemic or renal disease or who are concurrently taking nephrotoxic agents. Monitor patients receiving concomitant nephrotoxic agents for changes in serum creatinine and phosphorus.
Tobramycin: (Minor) Additive nephrotoxicity may occur with concurrent use of bacitracin and other nephrotoxic agents. When possible, avoid concomitant administration of systemic bacitracin and other nephrotoxic drugs such as aminoglycosides (particularly kanamycin, streptomycin, and neomycin). Use of topically administrated preparations containing bacitracin, especially when applied to large surface areas, with aminoglycosides may have additive nephrotoxic potential.
Torsemide: (Minor) Additive nephrotoxicity may occur with concurrent use of systemic bacitracin and other nephrotoxic agents. When possible, avoid concomitant administration of systemic bacitracin and other nephrotoxic drugs such as loop diuretics. Topical administration of any preparation containing bacitracin, especially when applied to large surface areas, also should not be given with other drugs that have a nephrotoxic potential. (Minor) Additive nephrotoxicity may occur with concurrent use of these medicines. When possible, avoid concomitant administration of systemic bacitracin and loop diuretics. Use of topically administrated preparations containing bacitracin, especially when applied to large surface areas, may have additive nephrotoxic potential with loop diuretics.
Valganciclovir: (Minor) Concurrent use of nephrotoxic agents, such as systemic bacitracin, with valganciclovir should be done cautiously to avoid additive nephrotoxicity.
Vancomycin: (Moderate) Additive nephrotoxicity may occur with concurrent use of systemic bacitracin and other nephrotoxic agents. When possible, avoid concomitant administration of systemic bacitracin and other nephrotoxic drugs such as vancomycin. Renal function should be monitored closely and vancomycin doses should be adjusted according to vancomycin serum concentrations if these drugs must be used together.

How Supplied

AK-Tracin/Baciguent/Bacitracin/Ocu-Tracin Ophthalmic Ointment: 1g, 500U
BaciiM/Bacitracin Intramuscular Inj Pwd F/Sol: 50000U
Bacitracin/Bacitracin Zinc Topical Ointment: 1g, 500U

Maximum Dosage
Adults

IM not recommended; however, 100,000 units/day IM (not to exceed 25,000 units/dose IM) has been used for the treatment of pneumonia.

Geriatric

IM not recommended; however, 100,000 units/day IM (not to exceed 25,000 units/dose IM) has been used for the treatment of pneumonia.

Adolescents

IM not recommended; specific dosing for adolescents not available(use Children dosing - 1200 units/kg/day IM has been used for the treatment of pneumonia.)

Children

IM not recommended; however, 1200 units/kg/day IM has been used for the treatment of pneumonia.

Infants

> 2.5 kg: 1000 units/kg/day IM.
<= 2.5 kg: 900 units/kg/day IM.

Mechanism Of Action

Bacitracin is bacteriostatic in action but may be bactericidal, depending on the antibiotic concentration and the susceptibility of the specific organism. Bacitracin inhibits the incorporation of amino acids and nucleotides into the cell wall. Bacitracin interferes with the final dephosphorylation step in the phospholipid carrier cycle, which causes impedance of mucopeptide transfer to the growing cell wall. Bacterial plasma membranes are also damaged by bacitracin. If bacteria are susceptible to bacitracin, resistance usually develops slowly.
 
Bacitracin is active against many gram-positive organisms and some gram-negative organisms. Unlike penicillins, bacitracin is active against protoplasts. The gram-positive spectrum includes staphylococci (including some penicillin G-resistant strains), streptococci, anaerobic cocci, clostridia, and corynebacteria. Gonococci, meningococci, and fusobacteria are gram-negative organisms susceptible to bacitracin. Other susceptible organisms include Treponema pallidum, T. vincenti, and Actinomyces israelii. However, among systemic diseases, only staphlycoccal infections qualify for consideration for bacitracin therapy. Bacitracin is assayed against a standard and its activity is expressed in units with bacitacin 1 mg having a potency of not less than 50 units.

Pharmacokinetics

Bacitracin is most commonly administered topically or via ophthalmic administration, but it may also be given intramuscularly. There is no absorption of bacitracin from the normal GI tract, pleura, or synovia. There is minimal binding to plasma protein. Bacitracin distributes widely following IM administration, appearing in all body organs including ascitic and pleural fluids, but not in the CSF unless the meninges are inflamed. Bacitracin is excreted slowly by glomerular filtration following IM administration and, if given orally, is excreted in the feces. After IM doses, 10—40% appears in the urine within 24 hours. Some bacitracin remains unaccounted for and is believed to be either retained by the body or destroyed. It is not known if any metabolism takes place.

Oral Route

Oral bioavailability of bacitracin is poor; when given orally, the drug is primarily used for local action within the intestines. There is no absorption of bacitracin from the normal GI tract. Bacitracin is excreted in the feces following oral administration.

Intramuscular Route

Absorption of bacitracin following IM administration is rapid, with maximum serum concentrations achieved in about 1—2 hours, ranging from 0.2—2 mcg/mL. Bacitracin distributes widely following IM administration, appearing in all body organs including ascitic and pleural fluids, but not in the CSF unless the meninges are inflamed. Bacitracin is excreted slowly by glomerular filtration following IM administration. After IM doses, 10—40% appears in the urine within 24 hours.

Topical Route

There is minimal absorption of bacitracin through normal skin. Bacitracin, however, is readily absorbed topically through large areas of denuded or burned skin or granulating areas.

Pregnancy And Lactation
Pregnancy

Topical or ophthalmic bacitracin use during pregnancy presents minimal risk to the mother and fetus. Topical bacitracin has not been associated with teratogenicity. Small-dose use has not been associated with risk to the fetus; however, large studies have not been conducted. There are no adequate data on the developmental risk associated with systemic bacitracin use during human pregnancy; bacitracin for injection is not indicated for adult use.

Topical or ophthalmic bacitracin use during breast-feeding presents minimal risk to the mother and fetus. Topical bacitracin has not been associated with teratogenicity. Small-dose use has not been associated with risk to the fetus; however, large studies have not been conducted. Only apply water-miscible cream or gel products to the breast because ointments may expose the infant to high concentrations of mineral paraffins. There are no data on the presence of bacitracin in human milk, the effects on the breast-fed infant, or the effects on milk production after systemic use; bacitracin for injection is not indicated for adult use.